桃红四物口服液微生物限度检查的方法验证

目的对桃红四物口服液微生物限度检查方法进行验证。方法采用平皿计数法,通过5种阳性对照菌回收率试验进行细菌、霉菌及酵母菌计数方法的验证;采用观察大肠埃希菌与金黄色葡萄球菌在相同环境下的培养来验证控制菌的检查方法。结果细菌计数采用培养基稀释法（即0.5ml/皿）,霉菌及酵母菌计数用常规法时,各试验菌回收率在70%以上;控制菌检查中,试验组检出大肠埃希菌,阴性菌对照组未检出金黄色葡萄球菌。结论本方法简便可行,结果准确,适合于微生物限度检查。     

活骨胶囊的微生物限度检查方法学验证研究

目的建立活骨胶囊的微生物限度检验方法。方法按《中国药典》2005年版规定,分别采用常规法、培养基稀释法、离心加薄膜过滤法对样品进行微生物限度检查。根据5株阳性对照菌的回收率结果进行其方法学验证试验研究。结果活骨胶囊含有药材原粉,并且具有抑菌活性,离心加薄膜过滤法能有效的去除其抑菌活性。结论用该法进行微生物限度检查,可以客观地反映药物中微生物的污染状况,可达到检测目的。     

三种中药制剂微生物限度检查方法学验证

目的建立3种中药制剂微生物限度检查方法。方法按《中国药典》2010版的规定,对肾炎清片、济生肾气胶囊、健肾颗粒进行微生物限度方法学验证。结果肾炎清片、济生肾气胶囊、健肾颗粒常规法检测时试验菌回收率均大于70%,控制菌可用常规法检出。结论采用常规法对肾炎清片、济生肾气胶囊、健肾颗粒进行微生物限度检查,可有效控制其质量,且方法简单、快捷。     

维生素B6氯化钠注射液无菌检查方法验证实验

目的建立维生素B6氯化钠注射液无菌检查方法。方法按《中国药典》2005年版无菌检查法验证实验的有关要求,采用簿膜过滤法,将300ml／筒供试品按薄膜过滤法滤过,无冲洗量,阳性对照菌为金黄色葡萄球菌。结果经方法验证,供试品组、阴性对照组均无菌生长,试验组各滤器中试验菌与阳性对照组比较均生长良好,说明供试品的该检验量和检验条件下无抑菌作用或其抑菌作用可以忽略不计。结论该方法简单、可行,可作为维生素B6氯化钠注射液的常规无菌检查方法。     

退热贴微生物限度检查方法的验证

目的建立退热贴微生物限度检查方法。方法参照《中国药典》2010年版微生物限度检查方法,采用常规法进行该药品的微生物方法学验证。结果采用常规平皿法时,大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、白色假丝酵母菌、黑曲真菌的回收率均高于70%,细菌、真菌和酵母菌计数采用常规平皿法,控制菌金黄色葡萄球菌、铜绿假单胞菌采用常规法检查。结论常规法可用于退热贴的微生物限度检查。     

注射用磺苄西林钠无菌检查方法验证实验

目的建立注射用磺苄西林钠无菌检查方法。方法按2005年版《中国药典》无菌检查法验证试验的有关要求,采用簿膜过滤法。将15瓶供试品,全部溶解于约500mL无菌氯化钠注射液中,按薄膜过滤法用3只滤筒滤过,每膜以400mL0.1%蛋白胨水溶液冲洗。阳性对照菌为金黄色葡萄球菌。结果经方法验证,供试品组、阴性对照组均无菌生长,试验组各滤器中试验菌与相应阳性对照组比较均生长良好,说明供试品的该检验量和该检验条件下无抑菌作用或其抑菌作用可以忽略不计。结论该方法可作为注射用磺苄西林钠的常规无菌检查方法。     

注射用头孢菌素无菌方法验证

目的完善头孢菌素类药品注射剂的无菌检验方法。方法以2种头孢菌素类注射剂为例,采用薄膜过滤法进行适度冲洗并加入适量青霉素酶消除供试品的抑菌作用,通过对阳性对照菌、冲洗量及青霉素酶的加入顺序等条件的优化,建立了无菌检查方法。结果头孢替安、头孢哌酮钠舒巴坦钠两种头孢菌素注射剂对7株阳性代表菌有不同程度的抗菌活性;无菌检查法必须建立在验证试验的基础上。结论本实验建立的无菌检查方法准确、可靠,建议将其收载入《中国药典》。     

复方利嗓胶囊的制备与临床应用

目的:对复方利嗓胶囊的制备工艺和临床应用进行研究。方法:采用随机数学表法进行非盲法多中心随机对照临床研究,与黄氏响声丸进行比较验证。结果:试验组总有效率86.7％,对照组总有效率为88.3％,开放组总有效率为88.3％,P>0.05。结论:复方利嗓胶囊制备工艺合理,临床疗效可靠。     

复方氨基丁酸维E胶囊辅助拉莫三嗪对小儿癫痫认知功能、脑电图及不良反应影响

目的 探讨复方氨基丁酸维E胶囊辅助拉莫三嗪对小儿癫痫的认知功能、脑电图及不良反应的影响.方法 选取2020年1—12月邢台市人民医院收治的120例癫痫患儿为研究对象.采用随机数字表法将患儿分为常规组与观察组,每组各60例.常规组患儿采用拉莫三嗪治疗,观察组患儿采用拉莫三嗪联合复方氨基丁酸维E胶囊治疗.比较两组患儿治疗前...     

胶囊内镜检查前胃肠道准备方法的探讨

目的：探讨适宜胶囊内镜检查前的胃肠道准备方法。方法：对我院接受胶囊内镜检查的62例患者采用6种方法进行胃肠道准备，并进行对比研究。结果：方法3、6肠道内气泡明显少于方法1、2、4、5；方法1、4肠道内食物残渣明显多于方法2、3、5、6。结论：检查前1d晚8时及检查当日5时分别服用甘露醇或复方聚乙二醇电解质散，并于检查前0．5h加服二甲基硅油散是比较理想的胶囊内镜检查前的胃肠道准备方法。     

Cardiac output determination during intravenous cardioangiography using x-ray fluorescence analysis

Cardiac output was determined with an indicator dilution technique during digital venous angiography of the left ventricle in 11 patients. The contrast medium injected into the right atrium was used as indicator. During and after the injection of contrast medium one blood sample per second was obtained through a catheter placed in the descending aorta. The samples were analyzed for iodine content with x-ray fluorescence analysis and cardiac output determined ad modum Stewart-Hamilton. Thermodilution was used as a reference method. The results indicate that the indicator dilution method with the use of contrast medium might be used for calibration of videodensitometric methods for blood flow measurements.     

Standardisation of 85Kr

As part of a BIPM key-comparison of ⁸⁵Kr, a primary standardisation using internal gas proportional counting was performed. The supplied activity for the comparison was approximately 40 MBq and a two-stage dilution was required to reduce the activity concentration to a level suitable for gas counting. A new gas-handling rig was constructed for performing the dilutions. The dilutions, however, introduced significant uncertainties in the final result, so that additional methods suitable for measurement at higher activity levels were also used.A series of dilution ampoules with activities of 6 and 1 MBq were prepared in the new NPL gas-handling rig using inactive krypton as a diluent. Internal gas proportional counting was performed on each of the 1 MBq dilution ampoules. The proportion of the activity transferred to the counting system was estimated using pressure and volume data and the total ampoule activity calculated. Counting losses below the threshold were assumed to be 2%. The effect of changing the composition of the counting gas by inclusion of krypton was evaluated and found to not significantly change the gas gain, i.e. losses below the noise threshold (approximately 120 eV) remained essentially constant. The proportional counters were assumed to be 100% efficient with an uncertainty of 0.5% (k=1).Both 1 and 6 MBq ampoules were assayed by gamma-spectrometry using HPGe and NaI(Tl) detectors. This method resulted in an activity value with a smaller uncertainty than the primary method. Activity values for the three methods employed were consistent within the uncertainty of measurement.     

鼠疫耶尔森菌重组酶聚合酶核酸扩增荧光检测方法的建立

目的 建立一种简单,快速的重组酶聚合酶核酸扩增技术检测鼠疫耶尔森氏菌的方法.方法 基于耶尔森氏菌的特异性序列设计引物及探针;通过对不同温度的检测来优化反应温度;通过对不同菌株的DNA模板进行检测评价该方法的特异性;通过对不同稀释浓度的样本DNA模板进行检测来确定灵敏性;通过模拟样品进行应用评价.结果 基于鼠疫耶尔森菌的...     

15 N-尿素发射光谱分析法检测幽门螺杆菌感染

目的：建立检测幽门螺杆菌感染的无损伤、无放射性方法－－^15N-尿素发射光谱分析法。方法：对26例受检者^15N-尿素发射光谱分析法检测其幽门螺杆菌感染。结果：诊断特异性为81％，灵敏度为89％，阳性预测值为84％。结论：该方法具有一定的实用意义。     

人体皮肤Merkel细胞原代培养与鉴定

目的探索人体皮肤Merkel细胞体外培养方法,为进一步研究银屑病发病中Merkel细胞的神经内分泌调节作用积累基础资料。方法获取正常人皮肤组织,采用酶消化法分离细胞。设计专门的细胞体外培养系统,观察Merkel细胞在3种不同培养液中贴壁和增殖情况。采用Merkel细胞特异性标记抗体CK20标记Merkel细胞,采用免疫组化和流式细胞仪进行鉴定。结果人体皮肤Merkel细胞在3种培养液中均能顺利贴壁和增殖,并具有内分泌功能,但1号培养液[ Hamˊs-F12＋胎牛血清（10/100 ml）＋bFGF（20 ng/ml）]更有利于Merkel细胞生长。经流式细胞仪鉴定,Merkel细胞纯度可达90.11%。结论在本培养系统中,人体皮肤Merkel细胞能成功进行体外培养,并可获得较高纯度的Merkel细胞。     

食蟹猴骨髓基质干细胞体外诱导分化的实验研究

为观察食蟹猴骨髓基质干细胞（BMSC）体外培养及诱导分化情况，分离食蟹猴的BMSC，以神经干细胞培养液和分化诱导因子进行体外培养和诱导分化。结果发现，分离得到的食蟹猴BMSC能在体外培养中增殖，分化，这些具有克隆能力的BMSC能表达神经干细胞特异性抗原Nestin，并能进一步诱导分化出胶质细胞样细胞和神经元样细胞，免疫细胞化学检测可见有GFAP和NSE抗原表达。提示灵长类BMSC是多分化潜能细胞，具有较强的自我更新和多分化能力，在适当的诱导分化条件下可形成具有神经系细胞（神经元和神经胶质细胞）特征的细胞；BMSC可作为神经干细胞的种子细胞。     

Image artifacts at high photon fluence rates in single-crystal NaI(T1) scintillation cameras

A method that simulates a clinically relevant situation is used to measure the amount of pulse pileup in the gamma image by distinguishing between correctly and incorrectly positioned events. Comparison was then made between responses from different cameras. These investigations show the influence of pileup rejection on counting rate. Pileup effects can be determined for some cameras at such low count rates as about 10,000/sec with a 30% energy window. Parameters affecting the total count rate of the scintillation camera--such as scattering media, source geometry, collimator, and energy window--have been investigated. It is shown that the energy distribution of the photon fluence striking the crystal determines the counting losses and image distortion, rather than the counting rate in the energy window. The approach described here might fulfill the requirements for a new method to compare scintillation cameras. It is important to note that measurements without scattering medium yield results irrelevant for clinical situations.     

人骨髓间充质干细胞定向成骨诱导中碱性磷酸酶对其成骨能力的影响

目的 探讨定向诱导人骨髓间充质干细胞(hBMSCs)分化为成骨细胞过程中,碱性磷酸酶(ALP)对hBMSCs成骨能力的影响. 方法抽取骨髓,梯度离心法分离单个核细胞,在DMEM条件培养基诱导hBMSCs定向分化为成骨细胞;相差显微镜观察成骨细胞形态,MTT法检测成骨细胞增殖,测定成骨细胞ALP分泌量及成骨细胞胞内ALP含量,RT-PCR检测成骨细胞ALP mRNA的表达. 结果梯度密度离心和黏附贴壁法联合使用可得到均一的hBMSCs;体外定向诱导过程中,成骨细胞ALP含量和ALP mRNA的表达在定向诱导10 d左右开始显著升高,成骨细胞的增殖能力明显增强.随着传代次数的增加,成骨细胞的增殖能力和碱性磷酸酶分泌量以及ALP mRNA的表达呈下降趋势,与BM-Purple染色结果一致. 结论 hBMSCs经定向诱导后可以分化为成骨细胞,ALP含量的变化能够显著影响hBMSCs诱导成骨的能力.     

Calibration of KRISS reference ionization chamber for key comparison of (99m)Tc measurement

KRISS, as the national metrology institute of Korea, has used a reference ionization chamber system to certify the activity of (99m)Tc aqueous sources, but could only recently participate in a comparison exercise by the BIPM (BIPM.RI(II)-K4.Tc-99m) to secure the international equivalence of (99m)Tc radioactivity measurement by way of the BIPM transfer instrument (SIRTI). The KRISS ionization chamber system was calibrated about 100 days before the comparison with a (99m)Tc solution source standardized by the 4πβ(LS)-γ(NaI(Tl)) coincidence counting method. During the comparison, beginning with a higher activity mother solution, the KRISS ionization chamber measured its specific activity without a dilution. The activity of a diluted-solution source was measured by the SIRTI at the same time.     

抑瘤素M在毕赤酵母中的表达及活性鉴定

目的：构建抑瘤素M（oncostatinM,OSM)的酵母表达体系,方法：将人OSM cDNA连入pPIC9K酵母表达载体,转染毕赤酵母（Pichia pastoris),用MD和MM营养缺陷型培养基筛选具有正确表型的重组转化子,用RNA印迹法和蛋白质印迹法鉴定母转化菌株中OSMmRNA转录和OSM相对分子质量。MTT法鉴定OSM蛋白对人黑素瘤细胞生长的抑制活性。结果：构建的毕赤酵母体系可实现人OSM分泌表达,表达量占外分泌蛋白的70％以上,表达蛋白相对分子质量约30000,对黑素瘤细胞生长可产生明显抑制作用。结论：OSM的酵母分泌表达体系表达量可观,表达蛋白集中于培养液上清,便于纯化,是日后进行OSM大规模制备的可行途径。